Three More Amici Filings in Myriad Discussed

The Patent Doc blog has posted summaries and analyzed three more amici filings in the Myriad case. Three separate briefs were submitted by the following persons/organizations:

Dr. Christopher Holman, Associate Professor of Law at the Universityof Missouri-Kansas City
Dr. James Watson (you've probably heard of him. Discovered DNA or something)
The Biotechnology Industry Organization (BIO) and the Association of University Technology Managers (AUTM)

Dr. Holman focused on scientific inaccuracies in previous rulings. One, he pointed out that isolated DNA does have different characteristics than DNA on the chromosome. He also notes that the DNA used in BRCA testing is actually a synthetic copy of the native gene and not one just cleaved out. Two, he challenges the goverment's argument that isolated genomic DNA and cDNA are fundamentally different. He does so good a job that he may inadvertently supply a reason to consider patent eligibility to cDNA -- possibly missing the "forest for the genes" by being so science focused.

Finally, he points out that claims as to the utility of isolated genomic DNA being restricted to use as probes/primers in diagnostic tests misses the boat with regard to their most important use being in production of recombinant proteins. And, he further challenges the assertion that patents on DNA gene sequences necessarily blocks any research or diagnostic relating to that gene. On the contrary, many sequencing techniques now don't rely on gene isolation to enable the technique and claims could be written to fall outside of current patents. He concludes that any determination that isolated DNA is patent ineligible will cause serious damage to biotechnology.

Dr. Watson takes the position that human genes should not be patented. He has three main points. DNA is a unique moleculre different from other chemicals (as it is self-replicating among other things and contains the genetic code) and should be treated as such from a patent point of view. The Patent Doc blog author notes this is a policy statement and as such not something the court shoudl consider as a matter of law in their power to change. Secondly, Dr. Watson says that human genetic information should not be controlled by legal monopolies or the private property of any company. The blog auther notes the gene sequence is patented and not the information from that gene. Further, the author notes that the biotech industry depends on its patents to secure rights for development funding from VCs and the public.

Finally, Dr. Watson brings up the point that the patents can result in a thicket that could block commercialization of genetic diagnostic testing. The Patent blog opines that the prototype diagnostic tests being proposed now would not be encumbered by these patents. And that patents are needed to spur investment. Dr. Watson's compulsory licesne concept therefore would likely chill investment and prevent introduction of these technologies not from the formation of a patent thicket but from a lack of commercial funding to development them in the first place.

That brings us to the amicus brief filed by BIO and AUTM in direct support of Myriad. They state that DNA sequences should remain patent eligible and that the Supreme Court's finding in Mayo v. Prometheus did nothing to change that. Mayo simply does not apply to composition of matter claims and any interpretation to the contrary is folly. Therefore the Court's reasoning in Mayo, a case about patent eligibility of method claims, should not be applied to manufacture of the composition of matter claims. They further state in their brief that if the Supreme Court had meant to examine composition of matter claims they would have cited findings in both Diamond v. Chakrabarty and Funk Bros Seed Co. v. Kalo Inoculant Co. as the proper precedent.

Finally, they two cite 30 years of precedent for allowing DNA sequence claims to be patent eligible. They contend that the overwhelming public policy balance favors sticking with prior policy. Again, citing the economic necessity of patent holders to rely on IP protections to leverage for development funds and to spur further innovation. They cite several examples of products produced using isolated DNA sequences including erythropoeitin, rapamycin, muromab-CD3 (anti-transplant rejection mAb), phytase (enzyme used to reduce phosphate pollution) and a host of enzymes used in biofuels. Basically, you don't only touch diagnostics tests but effect many other important areas of biotechnology with a "you can't patent gene sequences ruling".

Posted by Bruce Lehr Jul 16th 2012